Safety IssuesNCT04188821
Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander
A study testing breast drain removal in people with Safety Issues and Quality of Life, run by University of Foggia.
Trial summary
The experimental hypothesis of this randomized controlled study was to demonstrate that early drain removal in patients who underwent immediate breast reconstruction with tissue expander is a safety procedure to improving clinical outcomes and quality of life (QoL). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Safety Issues, Quality of Life
- What is being tested?
- breast drain removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SNS (skin nipple sparing) or SS (skin sparing) mastectomy for breast cancer and immediate positioning of breast expander (without mesh) with placement of suction drain, regardless of TNM classification
Who cannot join
- skin reducing mastectomy, reconstruction with flap, direct to implant reconstruction (with or without mesh or ADM) and axillary dissection
About this study
Official title: Reduction of Seroma and Improvement of Quality of Life After Early Drain Removal in Immediate Breast Reconstruction With Tissue Expander. Preliminary Report of a Randomized Controlled Study
The experimental hypothesis of this randomized controlled study was to demonstrate that early drain removal in patients who underwent immediate breast reconstruction with tissue expander is a safety procedure to improving clinical outcomes and quality of life (QoL). The mechanism of action underlying the proposed approach was intuitive. The early drain removal allows to: 1) avoid continuous seroma development caused by active suction of drain (stopping the circle "drain itself may perpetuate the drainage" with vacuum mechanism); 2) reduce the risks connected to "foreign body reaction" as tissue inflammation and infection; 3) improve QoL reducing pain, length of hospital stay and limitations of daily activities.
- Conditions
- Safety Issues, Quality of Life
- Being tested
- breast drain removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast drain removalProcedure or surgery
Investigators remove the drains when the suction drain flow was less than 30 ml/day for at least 2 days or at discharge, with no further signs of infection, fluid collection or impaired wound healing ("complicated", see below). Ultimately, we removed drains 3 weeks postoperatively (21 days post op) even if the flow was higher than 30 ml/day. However, leakage or severe patient discomfort led to immediate drain removal at any time during postoperative care.
| Study group | Role | What they receive |
|---|---|---|
| output based group | Active comparator | Investigators remove the drains when the suction drain flow was less than 30 ml/day for at least 2 days with no further signs of infection, fluid collection or impaired wound healing Receives: Procedure: breast drain removal |
| early-removal group | Experimental | Investigators remove the drains at hospital discharge, 3-4 days after surgery, regardless of the output at that time Receives: Procedure: breast drain removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
total fluid volume (ml)
sum of drain volumes and volume of seroma aspirations if needed
Measured: 21 days
days with drainage
Measured: 21 days
days of seroma formation
period that drain or seroma aspiration is needed in days after surgery
Measured: 21 days
time until wound healing (days)
Measured: 21 days
infection (yes or not)
defined as the appearance of local signs/symptoms as erythema, edema, induration, increased pain, and a change in drainage to a purulent nature and fever, confirmed by swabs
Measured: 21 days
complicated wound healing (yes or not)
unclosed wound 3 weeks postoperatively
Measured: 21 days
Secondary outcomes (4)
pain (using Visual Analogic Score scale to measure intensity)
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10)
Measured: 21 days
disturbance in quality of sleep (yes or not)
Measured: 21 days
limitation in personal care, daily activities and social life (yes or not)
Measured: 21 days
disturbance in mobility (yes or not)
mobility as walking, running, driving
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start1 Sep 2016
- Primary completion31 Mar 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lembo Fedele, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188821
- Sponsor's protocol ID
- 01/2019
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Seroma and Improvement of Quality of Life After Early Drain Removal in Immediate Breast Reconstruction With Tissue Expander. Preliminary Report of a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04188821
- Acronym / sponsor ID
- 01/2019
- Conditions
- Safety Issues, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The experimental hypothesis of this randomized controlled study was to demonstrate that early drain removal in patients who underwent immediate breast reconstruction with tissue expander is a safety procedure to improving clinical outcomes and quality of life (QoL). The mechanism of action underlying the proposed approach was intuitive. The early drain removal allows to: 1) avoid continuous seroma development caused by active suction of drain (stopping the circle "drain itself may perpetuate the drainage" with vacuum mechanism); 2) reduce the risks connected to "foreign body reaction" as tissue inflammation and infection; 3) improve QoL reducing pain, length of hospital stay and limitations of daily activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| output based group | Active comparator | Procedure: breast drain removalInvestigators remove the drains when the suction drain flow was less than 30 ml/day for at least 2 days with no further signs of infection, fluid collection or impaired wound healing |
| early-removal group | Experimental | Procedure: breast drain removalInvestigators remove the drains at hospital discharge, 3-4 days after surgery, regardless of the output at that time |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SNS (skin nipple sparing) or SS (skin sparing) mastectomy for breast cancer and immediate positioning of breast expander (without mesh) with placement of suction drain, regardless of TNM classification
Key exclusion criteria (1 listed)
- skin reducing mastectomy, reconstruction with flap, direct to implant reconstruction (with or without mesh or ADM) and axillary dissection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breast drain removalInvestigators remove the drains when the suction drain flow was less than 30 ml/day for at least 2 days or at discharge, with no further signs of infection, fluid collection or impaired wound healing ("complicated", see below). Ultimately, we removed drains 3 weeks postoperatively (21 days post op) even if the flow was higher than 30 ml/day. However, leakage or severe patient discomfort led to immediate drain removal at any time during postoperative care. | Procedure or surgery | early-removal group, output based group |
Primary outcome
total fluid volume (ml)
Time frame: 21 days
sum of drain volumes and volume of seroma aspirations if needed
days with drainage
Time frame: 21 days
days of seroma formation
Time frame: 21 days
period that drain or seroma aspiration is needed in days after surgery
time until wound healing (days)
Time frame: 21 days
infection (yes or not)
Time frame: 21 days
defined as the appearance of local signs/symptoms as erythema, edema, induration, increased pain, and a change in drainage to a purulent nature and fever, confirmed by swabs
complicated wound healing (yes or not)
Time frame: 21 days
unclosed wound 3 weeks postoperatively
4 secondary outcomes
pain (using Visual Analogic Score scale to measure intensity)
Time frame: 21 days
disturbance in quality of sleep (yes or not)
Time frame: 21 days
limitation in personal care, daily activities and social life (yes or not)
Time frame: 21 days
disturbance in mobility (yes or not)
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing breast drain removal in people with Safety Issues and Quality of Life, run by University of Foggia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total fluid volume (ml) (time frame: 21 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.